Bladder Cancer Clinical Trial

A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)

Summary

A Phase II, Randomized, Multi-Center, Double-Blind, Comparative Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Olaparib for First-Line Treatment in Platinum-Ineligible Patients With Unresectable Stage IV Urothelial Cancer

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Full Description

This is a Phase II, randomized, double-blind, placebo controlled, multi-center, comparative global study to determine the efficacy and safety of durvalumab + olaparib combination therapy versus durvalumab + placebo (durvalumab monotherapy) as first-line treatment in patients ineligible for platinum-based chemotherapy with unresectable Stage IV urothelial cancer (UC).

View Eligibility Criteria

Eligibility Criteria

Inclusion criteria:

Provision of signed and dated, written ICF
Histologically or cytologically documented TCC/UC of the urothelium (including renal pelvis, ureters, urinary bladder, and urethra) also meeting the following: Unresectable, Stage IV disease; No prior systemic therapy for unresectable, Stage IV disease.
Ineligible for platinum-based chemotherapy defined as (i) in the opinion of the Investigator, unfit for carboplatin-based chemotherapy and (ii) meeting one of the following criteria: CrCl <60 mLmin calculated by Cockcroft-Gault equation; Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 audiometric hearing loss (25 dB in 2 consecutive wave ranges); CTCAE peripheral neuropathy; New York Heart Association Class III heart failure; ECOG 2.
Known tumor HRR mutation status prior to randomization.
World Health Organization (WHO)/ECOG performance status of 0, 1, or 2.
Patients with at least 1 RECIST 1.1 target lesion at baseline.
Ability to swallow oral medications.
Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.

Exclusion criteria

Active or prior documented autoimmune or inflammatory disorders.
Other invasive malignancy within 5 years before the first dose of the IP.
Major surgical procedure within 28 days prior to the first dose
Brain metastases or spinal cord compression unless the patient's condition is stable and off steroid for at least 14 days
History of active primary immunodeficiency.
Active infection including tuberculosis (TB)
History of allogenic organ transplantation.
Uncontrolled intercurrent illness
Prior exposure to a PARP inhibitor or immune-mediated therapy.
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Current or prior use of immunosuppressive medication within 14 days before the first dose of the IP.
No radiation therapy is allowed, unless it is (1) definitive radiation that had been administered at least 12 months prior; (2) palliative radiation to the brain, with associated criteria for stability or lack of symptoms; or (3) palliative radiation to painful bony lesions (this must comprise less than 30% of the bone marrow) or symptomatic pelvic soft tissue mass(es).
Receipt of live attenuated vaccine within 30 days prior to the first dose of the IP.
Patients with a known hypersensitivity to durvalumab, olaparib, or any of the excipients of the products.
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab.

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT03459846

Recruitment Status:

Active, not recruiting

Sponsor:

AstraZeneca

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There are 43 Locations for this study

See Locations Near You

Research Site
Birmingham Alabama, 35294, United States
Research Site
Goodyear Arizona, 85338, United States
Research Site
Fort Myers Florida, 33901, United States
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Saint Petersburg Florida, 33705, United States
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Tampa Florida, 33612, United States
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Louisville Kentucky, 40202, United States
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Bronx New York, 10461, United States
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New Hyde Park New York, 11042, United States
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New York New York, 10065, United States
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Philadelphia Pennsylvania, 19124, United States
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Nashville Tennessee, 37232, United States
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Tacoma Washington, 98405, United States
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Hamilton Ontario, L8V 5, Canada
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Newmarket Ontario, L3Y 2, Canada
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Sudbury Ontario, P3E 5, Canada
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Toronto Ontario, M5G 2, Canada
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Montreal Quebec, H3T 1, Canada
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Incheon , 21565, Korea, Republic of
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Seoul , 02841, Korea, Republic of
Research Site
Seoul , 03722, Korea, Republic of
Research Site
Seoul , 05505, Korea, Republic of
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Seoul , 135-7, Korea, Republic of
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Moscow , 10507, Russian Federation
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Moscow , 12536, Russian Federation
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Novosibirsk , 63010, Russian Federation
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Omsk , 64401, Russian Federation
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Saint Petersburg , 19527, Russian Federation
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St. Petersburg , 19435, Russian Federation
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St. Petersburg , 19917, Russian Federation
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Barcelona , 08036, Spain
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Madrid , 08035, Spain
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Madrid , 28041, Spain
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Málaga , 29010, Spain
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Santiago de Compostela , 15706, Spain
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Kaohsiung , 807, Taiwan
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Kaohsiung , , Taiwan
Research Site
Taichung , 40705, Taiwan
Research Site
Tainan , 704, Taiwan
Research Site
Taipei , 10002, Taiwan
Research Site
Taipei , 104, Taiwan
Research Site
Taipei , 112, Taiwan
Research Site
Taoyuan City , 333, Taiwan
Research Site
Hanoi , 10000, Vietnam
Research Site
Ho Chi Minh city , 70000, Vietnam
Research Site
Ho Chi Minh , 70000, Vietnam

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

154

Study ID:

NCT03459846

Recruitment Status:

Active, not recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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